The B2B Podcast Index
Project Medtech

Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund

Project Medtech · 2026-06-15 · 46 min

Substance score

51 / 100

Five dimensions, 20 points each

Insight Density11 / 20
Originality10 / 20
Guest Caliber13 / 20
Specificity & Evidence9 / 20
Conversational Craft8 / 20

Dr. Malcolm Townes discusses how Washington University's Gap Fund supports early-stage medical device commercialization by funding technology development rather than new ventures, focusing on customer discovery and market validation before spin-outs. The fund takes a hands-on approach with milestone-based disbursements and pairs researchers with commercialization consultants to bridge the gap between academic research and market-ready products.

Key takeaways

  • Gap Fund focuses funding on technology development within the university rather than investing in new ventures, avoiding conflicts of interest while maintaining strategic control over commercialization direction
  • Customer discovery conducted with expert consultants is critical for preventing dangerous assumptions about target users and identifying true unmet clinical needs that drive product development priorities
  • Researcher coachability - the ability to receive feedback non-defensively and adjust based on market and customer insights - is the single most predictive factor for technology commercialization success
  • Pairing academic researchers with experienced commercialization advisors, entrepreneurs-in-residence, and service providers creates a tailored support system that matures technologies before New Ventures team handles business formation
  • Early engagement with FDA regulatory pathways and market access analysis prevents researchers from optimizing wrong product features and ensures readiness for investment before spin-out

Topics in this episode

What our scoring noted

Our reviewer’s read on each dimension, with quotes from the episode.

Insight Density

11 / 20

The episode contains a handful of genuinely useful insights for medtech operators - particularly the three-tier validation framework (FDA, payer, clinical adoption) and the structured approach to customer discovery - but a significant portion of the runtime is consumed by biographical background, geography small talk, ecosystem boosterism, and book recommendations. The insight-to-filler ratio is below average for a 46-minute episode.

what may be needed to validate for the FDA or for clear requirements might be completely different than what they need to validate, um, for market access and reimbursement and to convince payers to pay for technology. Um, and that may be different. Both of those may be different from what you really need to convince the customer or the target user
if there was only one factor that I could use to try and make a decision about whether or not a technology or gapflame, uh, project is going to be successful or unsuccessful, it will be coachability, without a doubt

Originality

10 / 20

The 'you might be the outlier in your own target user group' framing and the three-tier validation distinction are genuinely useful practitioner insights not commonly articulated this clearly. However, the core messages - customer discovery matters, coachability predicts success, FDA clearance isn't market access - are well-established in the medtech commercialization world and don't represent deeply contrarian or first-principles thinking.

there's always the potential for expert blindness and thinking that expertise in one area automatically translates into expertise in another area
even though you're part of that target user group, you might actually be the outlier in the target user group in terms of, um, how you're using it, how you're thinking about it, the job to be Done

Guest Caliber

13 / 20

Malcolm Townes is a genuine practitioner - he built and currently operates WashU's Gap Fund, has 10+ years of hands-on tech transfer experience across multiple institutions, and holds a PhD specifically in technology transfer policy. He is not a thought-leader or career speaker; he is describing work he actually does. His seniority is mid-level institutional rather than executive operator, which limits the ceiling.

about February 2023 made the move over to Washu, basically to set up the Washu Gap Fund and get that um, up and running and operating
I worked there for 10 years in their tech transfer and economic development office

Specificity & Evidence

9 / 20

There are a handful of real specifics - the $1B NIH research figure, a named technology (malignant edema stroke prediction by Dr. Raj Dhar), a named fellow (Bryce Sotomayor), and the IoT gateway real-time data assumption example - but outcomes, timelines, fund sizes, number of portfolio projects, and success metrics are almost entirely absent. The examples are real but underdeveloped.

WASHU does about um, a billion dollars worth of research, um, with the nih
Dr. Raj Dhar...and his technology for um, predicting um, malignant, um, edema, strokes

Conversational Craft

8 / 20

The host lands one genuinely sharp follow-up - asking how WashU pressure-tests customer discovery findings beyond its own health system - but the majority of the conversation is soft validation ('Yeah, yeah,' 'That's great insights'), irrelevant personal anecdotes (his wife's physical therapy program), geographic small talk, and a book-recommendation segment that adds no B2B value. No claims are challenged and no follow-up numbers are demanded.

how does Washu, then, in this customer discovery piece, partner with other hospitals, universities, you know, to do some of this customer discovery? Because to your point, what might be right for your health system and your ecosystem that might just be unique to your health system
Um, um, so yeah, that's, that's, that's great insights

Conversation analysis

Computed from the transcript - who did the talking, and the verbal tics along the way.

Share of words spoken

  • Speaker A67%
  • Speaker C28%
  • Speaker B5%

Filler words

um233so104uh74you know41like20sort of16actually11right11er7kind of7obviously5basically3I mean2

Episode notes

In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to uncovering “unknown unknowns,” preventing expert blindness, and aligning products with real clinical workflows. The conversation also explores how WashU leverages EIRs and Venture Fellows to add commercialization horsepower, why “coachability” is the strongest predictor of success, and what innovators most often miss: FDA clearance isn’t enough - market access and reimbursement require different proof, data, and strategy. Dr. Malcolm Townes LinkedIn Washington University in St. Louis Gap Fund Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law and JumpStart Inc .

Full transcript

46 min

Transcribed and scored by The B2B Podcast Index.

Speaker A: Foreign. Starts with medical discussion talking about the future. What comes Next with Project MedTech?

Speaker B: Hello everybody, I'm Lindsay Deneen, Director of Marketing engagement at Project MedTech and welcome to another episode of the Project MedTech podcast. If we can help you in any way, or you would like to suggest a future guest, you can email us@ah, infoorojectmedtech ah.com if conversations like this are helpful. That's exactly why we bring people together at our signature events, the Midwest Showcase, the Startup Symposium, and Coming to America. For more on our events that include networking, education and pitch competitions for startups, check them out@www.projectmedtech.com. we even have sponsorship options if your company is also dedicated to accelerating medical technology to impact patient lives. So reach out today to get involved. The Project Mentech podcast is proudly sponsored by Ward Law. Wardlaw Office LLC is a boutique law firm specializing in the practice of patent and trademark law. They are committed to providing inventors, entrepreneurs and businesses of all types with personal and professional services and are flexible to meet your unique needs. It is their goal to both educate on how to secure valuable patent and trademark protection and to provide high quality services at rates affordable to independent inventors, startups and small businesses alike. Without further ado, let's dive in.

Speaker C: Okay, Malcolm, welcome to the podcast.

Speaker A: Thank you for having me.

Speaker C: Absolutely. So Malcolm, uh, let's start with an introduction to who you are, your background and what you currently do at uh, Washu.

Speaker A: Sure, um, have a bit of an eclectic background. So. Ouch. I'm um, the. Currently my title is Innovation Fund Manager at Washington University of St. Louis in the Office of Technology Management. But basically I oversee uh, the technology development function within um, Washu's Office of Technology Management. Um, so education wise I have a uh, bachelor's in Mechanical Engineering from Missouri sat, um, and started my career doing project management work, then went back to school and got an MBA from Indiana University's Kelly School of Business. Um, and so I actually concentrated in entrepreneurship and marketing, uh, in that program. Um, and then once I earned my mba, went back in the industry, worked in product management primarily mostly uh, in industrial product company. So it was a really good learning experience. They like to pitch um, product management as sort of being um, an entrepreneur within a company. Uh, it's not quite like that, but it was very good experience having that uh, P and L responsibility, oversight of a product line, making um, pricing decisions, interacting with customers, things of that nature, getting involved in new product development. Um, and then I did a short stint in management consulting to um, um Basically do change management and process improvement work, um, which was another really good learning experience. And then came was uh, able to make the transition into tech transfer, um, at Missouri S and T, um, working there for 10 years in their tech transfer and economic development office, um, before being recruited to Saint Louis University's Tech Transfer office, um, serving as Associate Director for Technology Commercialization. And while I was at SLU, I went ahead and earned M. My Ah, PhD in Public and Social Policy. Really focused on technology transfer policy and science policy. Uh, and then, um, about February 2023 made the move over to Washu, basically to set up the Washu Gap Fund and get that um, up and running and operating. And so I've been overseeing that. And in the past few years we've sort of been thinking about how the office is structured, how we go about doing technology commercialization. And so that what started off as a focus on the Washington Gap Fund is sort of expanded into this function of technology development and being more strategic about developing the technology further.

Speaker C: Yeah, yeah, I want to get into um, the, the Gap Fund and how you've, you've, you've structured that. Um, but first. So, so you grew up in Missouri then? Um, yeah. How far. What are we talking about? From, from geographically. So, so again I think listeners are 60 to 65% North American, US Canada based. The rest are international. Um, so how far you know, is, is Missouri, uh, S And T to St. Louis. Is this close in the state of Missouri or.

Speaker A: Well, well, I'm in St. Louis and so S&T is about 100 miles southwest of St. Louis.

Speaker C: Oh, gotcha. Okay.

Speaker A: It's actually close enough that I actually commuted for 10 years.

Speaker B: Really?

Speaker A: So it was, it was an extreme commute. Yeah, I actually did that for, for 10 years.

Speaker C: Okay. Yeah, very cool. Um, all right. And then I think maybe just laying some of the land here for the St. Louis ecosystem. I know of Wash U University, which in St. Louis, which is super deceiving, um, because I think of the State of Washington, but I know of it because it has a physical therapy school. Um, and my wife, uh, is a physical therapist. So I think she, she might have applied and gotten into WashU, but ultimately stayed in Ohio. But regardless, um, Washu in St Louis. Is it a big university, small university? Talk to me a little bit about and what Washu is known for.

Speaker A: Yeah, it's a, um, private university, um, fairly significant. WASHU does about um, a billion dollars worth of research, um, with the nih. And so, um, there's a lot of research going on here, um, very closely affiliated with the um, BJC Barnes Jewish Healthcare System. Um, and so education wise and innovation wise, it's a major player here within the ecosystem, sort of one of the anchors here. Uh, um, so most of the research in terms of disclosures that we see come out of the medical school or the school of medicine. Um, and so I would say that's probably you know, 70, 80% in terms of disclosures that we're seeing if I were to ballpark it. But we also have very active uh, engineering department with a bio, um, mechanical, biomechanical engineering, um, field of discipline. Um, and so we see activities there. There's the, you know, the regular school of arts and sciences with chemistry and all of that. And so those research there. So there's a lot of research going on. So as an institution, WASU is very connected to other partners within the ecosystem such as Bio SDL and biogenerator. So the Office of Technology Management actually works fairly closely with those organizations. But within the ecosystem, uh, obviously there are other universities here that are doing research and other um, programs that are occurring um, within the area. So you know, Cortex as an innovation district, um, has developed quite a bit over the last 10 years. So um, WASHU has a strong presence there. It's right next to the medical uh, campus. Um, and so we're really integrated there as well. Uh, and then within the St. Louis uh, ecosystem there are other institutions like T. Rex, um, that sort of evolved over time. There are other programs that are providing um, mentoring, um, particularly around entrepreneurship, um, and innovation as well.

Speaker C: Yeah, super cool. Um, and in your role there, um, uh, the Gap Fund, which I want you to explain the setup of this here. But um, it could be more than just life sciences. Is that right or exactly yours? Okay. All right.

Speaker A: So, okay. The way we set up the Gap Fund, um, it really focuses on anything that's non drug or not therapeutic. They, we set it up particularly because we felt all these other areas weren't getting the support that they really needed. And uh, there weren't as many opportunities. When people think of tech, they tend to think of biotech a lot. And that's a very active area here in the St. Louis ecosystem. Uh, and so that tends to get a lot of focus. It tends to suck up a lot of the oxygen in the room. So we set up the GAP Fund to specifically provide support to all these other areas. And so it's very broadly defined as supporting any non drug, non therapeutic technology across the Washington community. But we hope to be Able to expand that support into, um, some of the therapeutics and the drugs in the future going forward. Yeah.

Speaker C: Very cool. Um, awesome. So tell me a little bit about the Gap Fund, because I think one of the things is we've seen a number of different ways that local universities create innovation departments and tie into the community and do these sorts of things. Um, and we've talked a handful of times and I wasn't aware that what your PhD was actually in. But you've obviously seen some of this as well and studied this. So tell me about how it's set up, how it's structured, why unique. Um, and maybe talk a little bit about the innovation ecosystem that Washu's created. Sure.

Speaker A: So when we set up the Washington Fund, we made some very specific choices. And one of them was that, um, the fund wouldn't make investments in new ventures. It would focus pretty narrowly on the technology itself. And so all of the awards are given to the faculty in their role as employees of the university. Um, and so what, they're working within the fence line of Washu. And we did that to really avoid a lot of the conflict of interest issues that may come up when you're trying to use a new business venture or startup as the vehicle for a lot of things. But it also gave us a bit more control over the process. Um, and so with the Gap Fund, we're really focused on trying to understand what's necessary to make the technology, um, competitive versus other solutions in the market, really achieving product market fit and really what's necessary to attain widespread adoption. Um, and so again, we're very focused on the technology itself and we set it up where we dispersed the funding, sort of entrancious, built around the work plan and certain key triggers or milestones as we work along and do projects. So for example, project you worked on where we were doing market, um, access and reimbursement analysis, so structuring that. So the disbursement was cover the initial invoice where it got started, um, and then another distribution once the project was complete and we got the deliverables and then make another disbursement. And so that gives us, um, control to make sure the money is being spent, um, strategically, um, the way it should be spent, um, and really enables us to really get involved with the projects, um, and really help structure them and focus on the important things in terms of commercialization, which, generally speaking, a lot of the programs that are critical concepts of Gap Fund type programs are sort of moving in the direction of being very involved Taking a very hands on approach, um, uh, having a little more control over the process as we go forward. Um, in that sense where we're not that unusual. But in terms of the focus on the technology and really not funding ventures per se, um, that's I think is pretty unique. But we do work really closely with the New Ventures team, um, that is again part of the Office of Technology Management. And their mandate is really to work with the faculty that are pursuing, um, new business ventures to commercialize their technologies and help them think about all the other things around that, you know, with the business model, um, the revenue strategy, um, the channels and all of those other things so they bring all that together. Um, and so within the ecosystem there is that support. But the Gap Fund we've made pretty narrowly focused on some things. Um, it makes it a bit easier to manage and um, a bit easier to achieve. Um, what we're trying to do, um, with the Gap Fund in terms of the desired outcomes we're trying to uh, accomplish here.

Speaker C: Yeah, yeah, and I think I told you that before the call as well is I was really impressed with um, the first company we worked with on that reimbursement assessment in terms of what they already had accomplished, um, in not just reimbursement but the other areas of their business. Even though it's not a business yet. Right. Funding the product, um, you still can control their startup and business readiness so that when they do spin out, um, they are really ready to take on capital. I mean that is generally a pretty big issue. We see is when we have companies that are spinning out of other universities, are they really ready to take on an answer. Those economic benefits that they're providing to the health care system, uh, whether it be payers, providers, clinicians, patients or all four, uh, you know those, those economic things are just hard. The merger of that with regulatory is difficult. And I just don't think enough early stage innovators are thinking about that. And so the fact that you can have some of that control to kind of push them down that route I think is really key and leads to probably really mature companies, uh, going to the new venture team, uh, and then being able to kind of pick that up, um, where you guys left it off. What are in your experience, these early stage innovators, what are some of the biggest things they struggle with when they come to you?

Speaker A: Yeah, so in my experience is really hard for them to separate the research from the business and make that transition. Um, they really tend to hone in on that research and focus on um, what science needs to be done, what type of science needs to be done, and that type of research. The way we've set up the Gap Fund, we're really able to, uh, slow them down. And everyone talks about doing customer discovery, um, but again a lot of the grants that they have access to, that's really not a component of the grants and they can't fund it. Um, and doing customer discovery takes quite a bit of effort. Uh, and it's a real skill that has to be developed. And again, the faculty aren't trained to do that and they're really not prepared and they have all this other things on the plate. So with the Gap Fund and the way we set it up, it really enables them to want to do the customer discovery. And so we can really force that issue, um, to have them do customer discovery on the front end to really engage and think about who are really the target users and understanding what is the job and the problem from their perspective and what are they really looking for in terms of the desired outcomes, um, going forward and how they approach their job, particularly how this technology might integrate within the clinical care workflow. And so we're able to really nudge them along to do that customer discovery work. And the way we've done this now is that we really pair them up with a service provider, um, that has that expertise, uh, in doing customer discovery. And so they work with them to define who that target user is and make sure that's correct work on the screeners, the dialogue. But the actual moderation they leave to that consultant while they're observing the, uh, interviews themselves. And then there are debrief sessions where they can talk about, okay, what came up, what type of issues, what adjustments do we need to make in terms of how we're doing these discussions? And going through that process really opens their eyes up and it either gives clarity on some things that they were thinking or refutes some assumptions that they were making, um, going into the project. So, great example is we have M1 faculty that's working on some Internet of Things technology gateway manager, um, going into it, he was operating under the assumption that real time data access was going to be important to the target users that he had envisioned for this and some other things. But going through that customer discovery, um, process and sitting in on those interviews really became apparent that that really wasn't the key issue. There were some other key issues that were really more important and so that real time data access wasn't really part of the minimum feature set. Um, and so had he not gone through that customer discovery experience, he would have gone down a path of really trying to optimize real time data access. Um, but it wouldn't really be creating value in making the technology competitive for a marketplace. And so it's that type of thing. It's very subtle but it's really important because it really informs how uh, the technology needs to be further developed, um, and structured and formulated to bring it to the market. Um, and even how you go about talking about it with target customers. Yeah, yeah.

Speaker C: So great. Example, let me ask you about the creation of the team here. Right. Because it's one thing to have the process have, you know, the fund set up appropriately. Okay, good. We like the strategy of how we're going to do this and we're going to move companies through and hand them off. And um, obviously there's plenty of innovation happening at WashU. So it's like you have all the ingredients. How do you get the teams to execute the plan? Now because that's the other big piece of this. A lot of ecosystems and universities will put together these really good plans and there's only so much planning you can do and so many different things you can do and it comes down to execution. So talk to me a little bit about that because we got some engagement with that.

Speaker A: Yeah.

Speaker C: When we did our project with uh, Beacon AI and we were really impressed with the internal work Squash U team as well that was working on helping the um, innovator through the process and build these things out. And so yeah, I'd love for you to talk a little bit about that and how you looked at building that team.

Speaker A: Yeah. So the research team is developed on their own. However they come together and however they come to us, that's how we take them. Um, there may be instances where we, we're evaluating a potential project and we're thinking, okay, um, they really need to have an advisor here, um, that has certain commercialization experience, a certain commercial experience within this domain. Um, because that's really what's missing. And so we'll either connect them um, in some way or try to help them connect. But the other nice thing is that within a um, New Ventures team that we have an EIR program entrepreneur in Residence. So for those that are considering um, going through um, the process of launching a new business venture, um, there's the opportunity to try and connect them within EIR that can help play that role. We also have this New Venture Fellows program that operates uh, out of the New Ventures team. And so every year for the past couple of years we've, we've able to, been able to have, you know, four or five or so fellows that are learning about entrepreneurship and technology, entrepreneurship, learning about, you know, business models and the value propositions and relevant frameworks, but then being able to apply what they're learning on real projects. And so you take that type of um, assistance and, and apply it to these projects and have them work with um, the researchers and the research team to answer m, some of these questions. Um, and so, you know, for example, the, the project you worked on, Bryce, um, Sotomayor, you know, came out of that program, um, you've since been hired on, um, with um, the Office of Technology Management. And so he, you know, was assigned to work with, you know, that particular technology. In this case, uh, we're, we're talking about, uh, Dr. Raj Dhar, excuse me, uh, and his technology for um, predicting um, malignant, um, edema, strokes. And so, you know, you know, so now there's an extra resource to dig into some of these questions, these unknowns we might have. And then in that case it was around some of the market access and reimbursement where you can do some early work. So Raj and his um, team having gone through the initial customer discovery work, um, to understand what was going on with the customer and the customer's perspective, um, and really understand where the opportunity was to create value in confirming some things then going on, actually going through, um, an FDA regulatory analysis and actually going through the process, um, of engaging with the FDA through the Q submission process to get specific, um, definitive feedback before they start down the road of doing validation or anything, uh, of that nature. And so as they go through that, then the issues of market access and reimbursement came up and said, okay, well now let's connect them with another resource to help think through those issues. And that's when Project MedTech comes into the picture to help work through those issues. And so again, it's really fairly tailored um, to the individual opportunity. Uh, it's not one standard team plug, you just moving along to the next. Um, but the one thing that really makes all the difference, no matter what, is really the coachability of the researcher and the research team. And so we see it anecdotally, we haven't done any hard data on this, but we, we do get a sense that in those instances where the researchers are really coachable, meaning they take feedback in, they engage, they're not defensive, they're really trying to understand what the issues are and adjust accordingly. Um, and Going through that process really actively. When they're coachable, the outcomes are a lot better, the process goes a lot smoother. And so if there was only one factor that I could use to try and make a decision about whether or not a technology or gapflame, uh, project is going to be successful or unsuccessful, it will be coachability, without a doubt. That would be one factor that seems to be the most predictive.

Speaker C: Yeah, yeah, I can totally see that. I mean, we see it all the time, um, with technical founders that struggle with the clinical. You know, you have to have clinical validation beyond just does your device work or not? You have to have clinical validation around the economic impact you're creating. And I think that's just like a, I, I, I don't know if it's like a difficult place to, or a difficult piece for them to talk about, but generally you're working with clinicians, scientists and engineers and um, um, you know, healthcare is about saving lives and improving lives, but it's also a business and, and there's that unsexiness of having to talk about that business aspect. I think some of these clinicians probably, probably struggle, um, with a little bit and that coachability of, uh, hey, I know how this product is going to get used in the clinics. And it's like, hey, we know that, but we still got to talk to other people.

Speaker A: And that's really one of the most dangerous assumptions they can make. That's one of red flags. Me, I talked about one side. The factor that's the biggest red light and coachability, the biggest red flag is that assumption that I know what's best for the target user. Um, and I understand how they can come to that because they are experts in their field. You know, they've been doing this for a long time. They have a lot of knowledge, they do know a lot, a lot. Um, but there's always the potential for expert blindness and thinking that expertise in one area automatically translates into expertise in another area. Uh, and that's just not the case. And a lot of times what I like to say is, you know, there's always a possibility that you might be the outlier. You know, in terms of, if you're an innovator, um, creating technology for the field that you actually do clinical practice work for, there is the possibility that, yeah, even though you're part of that target user group, you might actually be the outlier in the target user group in terms of, um, how you're using it, how you're thinking about it, the job to be Done. And so it's very dangerous to try and generalize from your own personal experience to the broader market. And so another way to think about it is, okay, great, you think one thing, or you have this particular assumption about how the user will apply the technology or how the technology is going to be used in the situation. Okay, prove it. You're a scientist. Prove it to me. And that's where that some of the discovery work comes in, because that's how you test the assumption and prove or disprove whether the assumption is valid.

Speaker C: Yeah, it's funny, I recorded another podcast this morning, and someone was talking about, One of the guests was talking about that this morning of customer discovery, and he was describing a scientific method. And I'm like, imagine that the scientific method actually works. You know, um, but, but, uh, so, so let me ask you, how does Washu, then, in this customer discovery piece, partner with other hospitals, universities, you know, to do some of this customer discovery? Because to your point, what might be right for your health system and your ecosystem that might just be unique to your health system or that physician? And so how do you pressure test that with other geographies across the US or world?

Speaker A: Well, when we structure, um, these engagements, we specifically, um, specify that the respondents should not be part of the WASHU community or the community, um, so they should be from outside. They shouldn't be close colleagues of the inventors. Um, and so with those directions, then, um, the consultant and the researchers, as they're working on the project, they try and find respondents outside of the area and try to get a general, um, broad geographic representation, uh, and maybe representation across different categories of, um, types of institutions, things of that nature. The. To try and make sure we're getting a fairly broad sort of representative sample, um, in terms of the feedback that we're getting. And again, it's not meant to be to the degree where we can get, um, statistical significance at a p value of 0.001 or anything like that. It's really more qualitative and trying to get the qualitative sense, okay, are we on the right track? What kind of issues are coming up that we haven't thought about? And really an opportunity to try and discover what the unknown unknowns are, the things that can really hurt you that you hadn't thought about and it doesn't even cross your mind to consider. Um, and you can really only get that by going out and engaging with the customers and target users and having those initial discussions through customer discovery and having a true discussion and not try and sell your technology in the conversation. Um, another important point.

Speaker C: Yeah. Um, so uh, let's expand back out to kind of the St. Louis ecosystem as a whole. Um, you know outside of winning the second most World Series titles and Major League Baseball. Um, uh, uh, what are some of the things that you know St. Louis's ecosystem does. Does well and what are some things that could use a little bit of. Of uh, could, could use more of? Um and, and I think like when I think of this I think of like yeah, how's the funding environment? I'm assuming healthcare wise you have good engagement through payers and obviously hospital systems, um innovation. But yeah, what are the things they do well? What are the things they can use more support on?

Speaker A: I think as ah, an entire ecosystem. St. Louis has really done well in becoming a player with regard to um biosciences and biotechnology and really establishing itself there is gaining um ground in terms of the um investment opportunities. Okay, investments opportunities. We do have some local venture capital firms. Um and you know with the example with the new ventures teams, they're very active in trying to make those connections with the venture capital community more broadly nationwide. Um, to make those connections as well. Um, but again that's still an area where I think locally we could um, stand and improve a little bit more. Um and I think the other challenge that we have a lot in the local ecosystem is um finding those initial C level leaders to come on board to startups and help them at that very early stage. Again we have these um, really technical founders and co founders um who are researchers at heart and that's really the other piece that they really need is that initial CEO that has that experience and background to come in and step in and work with them and really pilot the venture. Um and so I think that's a piece that we kind of struggle with. Is one of the reasons why uh OTM sort of set up the Entrepreneur and Residents program to try and sort of fill that void. Um but I think that's a very big gap. Um, I think some of the other exciting opportunities we see coming along locally in the ecosystem, um, you know SLU is a competitor and a partner so to speak. So another major research um institution here recently um became an R1 research institution. Um but they focused on really the geospatial, um domain, um, geospatial technology. Um and so with the recent investment um from NGA and you know building a whole new um infrastructure facility for uh, their operations uh in North St. Louis, um, that was a, I think a big Boost not just to the um, economic situation in North St. Louis, but just generally to um, the broader innovation, entrepreneurship ecosystem here locally. And so that creates you know, opportunities for other cutting edge, edge technology, um, and for you know, St. Louis to really, you know, make a mark within a specific um, technology domain. And so again I think there are lots of opportunities here but the, the main struggles, um, again funding, um, making improvements there. But there, there's you know, an opportunity um, to really um, make more improvement and make things a little bit easier. But I would say probably that C level experience in finding that CEO, uh, to get started is probably still a big impediment for um, ventures, particularly those that are going to be pursuing venture capital investment.

Speaker C: Yeah, yeah, it makes sense. Um, you know, the funding piece, it's like I think it's been getting better across the ecosystems that aren't Boston, New York and San Francisco where money seems to just kind of fall out of pockets. Right. Um, you know, but um, ah, I do think though, you know, it's like if local communities can solve for that early stage, let's seed a lot of these companies, those growth stage venture funds will find good companies. Um, and frankly the valuations are better in some of these other areas. Right. And so um, you know, that's the hope. But you still need those growth stage venture funds as well that can come in and that are local to a community, uh, that can fund, you know, some of these opportunities as well. Um, um, so yeah, I, I totally agree. I think that the um, the executive level, the you know, finding enough jockeys for these horses is, is just generally a problem. Um, um. And so, um, yeah, that's, that's, that's great insights. Um, okay, uh, uh, final, final questions. Um, here. Um, if there was one thing an early stage innovator would need to know about the US healthcare system, you've littered a lot of really good advice for them. But if there was, if there's one thing where it's like, hey, I'm thinking about innovating specific to the US healthcare system, what's that one piece that I need to know heading into that?

Speaker A: Oh yeah, well, it kind of centers around the one assumption that I see a lot of researchers making that if I get um, clinical validation or uh, get the approval from fda, uh, all is fine. That's the biggest hurdle. And it's um, getting what's called market access. Um, and getting payers to agree to pay for use of a technology is another hurdle, incredibly challenging hurdle that um, they really need to be aware of and need to understand that when it comes to data and validating a technology, there's different types of data and different types of validation. And so what may be needed to validate for the FDA or for clear requirements might be completely different than what they need to validate, um, for market access and reimbursement and to convince payers to pay for technology. Um, and that may be different. Both of those may be different from what you really need to convince the customer or the target user that the technology is worth adopting. You know, um, and so they need to be cognizant of that and how all of that plays together, interconnects, um, and, you know, understanding that and going through this process, um, of starting off with customer discovery, engaging with the FDA early to understand regulatory considerations and, and then thinking about market access and reimbursement issues early on, um, doesn't hurt. It helps you. And it will in some ways play into how you go about doing that scientific work that you want to do to mature the technology, refine it, and advance it going forward. Um, and so I know a lot of researchers want to jump in and do that work first. Um, but that's really, in my opinion, putting the cart before the horse. And you really need to do these other pieces first. Um, and be. And be cognizant of differences and nuance between the three sort of sets of data and validation that you really need to do.

Speaker C: Yeah, you know, the, uh, one of my favorite phrases as of recent is the FDA doesn't buy your medical device. Um, and, uh, yeah, but people need to understand that. Okay. Uh, obviously, judging, you can see in my background, I enjoy reading. I get most of my books from my guests. Um, so, um, uh, it could be fiction or nonfiction. Uh, it doesn't have to be nonfiction. Most people tendency to give me nonfiction books. And so, um, yeah, it's the first time I finally read multipliers. I'm listening to that audiobook. And I'm currently reading Science Lessons, which is a book about, uh, uh, Amgen. Uh, it's pretty good. Um, but, uh, yeah, book, ah, recommendation or two, if you have one.

Speaker A: Yeah, I'll give you two, One in each category. So in fiction, I would recommend book, um, that came out fairly recently called James by Percival Everett. It is a sort of retelling, reimagining of Mark Twain's Huckleberry Finn. Um, and I thought it was really well done, really interesting. Okay, well done. Um, with some interesting twists in it. So if you're familiar with the Huckleberry Finn story. If you read that, you know, in high school or grade school or anything like that, I think you'll find this a, uh, really interesting read, really engaging,

Speaker C: very cool. Awesome. I have it pulled up here now. I'm just. Yeah, I'm looking at it.

Speaker B: Okay.

Speaker C: Very good.

Speaker A: Yep. And the other one I would recommend is, um, Bernoulli's Fallacy. And I forget who the author is. And I read this a while ago and I, uh, I think it's been a while since it, it was published. But it's about statistics, um, and um, this sort of feud between the traditional frequentist statistics and Bayesian statistics. Uh, and so it sort of gets into that and sort of delves into what the author considers to be some fundamental flaws with frequentist statistics and that methodology, which we know is really predominant in our sciences. Ah. And research, that's the dominant statistical method that's used, um, in science today. And so if you're into that, more technical things, I think that'll be a really interesting read for you as well.

Speaker C: Uh, it's by Aubrey Clayton. I looked it up here. Um, yeah, very cool. I appreciate it. Malcolm. Uh, Malcolm, thanks for doing this. We'll have a link to, um, uh, your LinkedIn, the website, um, around Washu, uh, Gap fund information, that sort of thing. Um, but, um, yeah, thanks so much for joining me today. Hang on for one minute and we'll chat offline.

Speaker A: Great.

Speaker C: Hi, I'm Freddy Coffey, Director of Marketing at Jumpstart. The Project MedTech podcast is proudly sponsored by Jumpstart Inc. Jumpstart's Trailblazer accelerator helps Ohio's most innovative early stage health tech startups fast track their growth with tailored advising from serial entrepreneurs, non dilutive funding to fuel their journey, and unrivaled access to a network of experts, resources and investment opportunities. Whether it's improving patient outcomes, advancing digital health or reimagining care delivery, jumpstart provides the high impact services and critical resources to bring big ideas to life. Learn more@jumpstartinc.org startups.

Speaker B: Thank you for listening. At our core, we at ProjectMedTech are networkers, educators and consultants. We. We meet you where you are to bring value and to create impact. We care deeply about helping medtech companies succeed right from the start through to exit for providing consulting and fractional services, hosting impactful industry events, and of course sharing incredible guest insights like the ones you heard today through our podcast. Please reach out at any time. If we can be of assistance, check out our website@www.projectmedtech.com or email us at, uh, infoorojectmedtech.com.

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